RANDOMIZED COMPARISON OF ETOPOSIDE-CISPLATIN VS ETOPOSIDE-CARBOPLATINAND IRRADIATION IN SMALL-CELL LUNG-CANCER - A HELLENIC COOPERATIVE ONCOLOGY GROUP-STUDY

Purpose: To compare the efficacy and toxicity of etoposide and cisplat in (EP) with etoposide and carboplatin (EC) in combination with irradi ation in small-cell lung cancer (SCLC). Methods: Previously untreated patients (pts) with SCLC and measurable or evaluable disease were rand omized to receive either cisplatin 50 mg/m2 on days 1-2 or carboplatin 300 mg/m2 on day 1, both combined with etoposide 300 mg/m2 on days 1- 3 every 21 days for 6 treatment cycles. The vast majority of respondin g limited disease (LD) pts and complete responders (CR) with extensive disease (ED), also received thoracic irradiation (TI) and prophylacti c cranial irradiation (PCI) concurrently with the third cycle. Results : Of the 147 patients registered, 143 were eligible; median performanc e status (PS, WHO) was 1, and tumour stage was LD in 41 pts of each tr eatment group. The mean delay between cycles was 8 days in the EP grou p and 9 in the EC group increasing in both arms with the number of tre atment courses. The drug dose administered per unit time as a proporti on of the protocol dose was 74% and 80% for the two groups respectivel y. Leukopenia, neutropenic infections, nausea, vomiting, neurotoxicity and hyperergic reactions were more frequent and/or severe in the EP g roup. The CR rates were 57% and 58% for EP and EC respectively. Median survival for all pts was 12.5 and 11.8 months, respectively. Conclusi on: Both treatments proved to be effective, with no differences in res ponse and survival between the two treatment arms. The EC regimen was associated with significantly less toxicity.